Trial Outcomes & Findings for Aripiprazole Augmentation of SSRI Therapy in Treatment Refractory Depression (NCT NCT00608543)
NCT ID: NCT00608543
Last Updated: 2012-10-26
Results Overview
The SOC is part of the CAmbridge Neuropsychological Test Automated Battery (CANTAB) and is an executive function task based on the Tower of London test that assesses spatial planning for problems with 2, 3, 4, or 5 moves. The Mean Initial Thinking Time for 3-move problems is the time (in milliseconds)taken to plan a problem solution for trials requiring 3 moves. Higher numbers indicate poorer performance. Time reported is the difference between baseline and 6 weeks post-treatment.
COMPLETED
PHASE4
17 participants
baseline and 6 weeks
2012-10-26
Participant Flow
Participant milestones
| Measure |
Open-label Aripiprazole Augmentation
Aripiprazole augmentation of existing escitalopram, citalopram, or sertraline treatment was provided to study participants at a flexible dose between 5-15 mg (based on clinical symptoms and side effects) for 6 weeks
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|---|---|
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Overall Study
STARTED
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17
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Overall Study
COMPLETED
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13
|
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Overall Study
NOT COMPLETED
|
4
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Reasons for withdrawal
| Measure |
Open-label Aripiprazole Augmentation
Aripiprazole augmentation of existing escitalopram, citalopram, or sertraline treatment was provided to study participants at a flexible dose between 5-15 mg (based on clinical symptoms and side effects) for 6 weeks
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|---|---|
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Overall Study
Adverse Event
|
4
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Baseline Characteristics
Aripiprazole Augmentation of SSRI Therapy in Treatment Refractory Depression
Baseline characteristics by cohort
| Measure |
Open-label Aripiprazole Augmentation
n=17 Participants
Aripiprazole augmentation of existing escitalopram, citalopram, or sertraline treatment was provided to study participants at a flexible dose between 5-15 mg (based on clinical symptoms and side effects) for 6 weeks
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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17 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
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Age Continuous
|
48.18 years
STANDARD_DEVIATION 7.95 • n=5 Participants
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Sex: Female, Male
Female
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13 Participants
n=5 Participants
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Sex: Female, Male
Male
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4 Participants
n=5 Participants
|
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Region of Enrollment
United States
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17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 6 weeksPopulation: Completers; due to fact that testing occurred at pre- and post-intervention; mean represents difference between pre- and post-intervention
The SOC is part of the CAmbridge Neuropsychological Test Automated Battery (CANTAB) and is an executive function task based on the Tower of London test that assesses spatial planning for problems with 2, 3, 4, or 5 moves. The Mean Initial Thinking Time for 3-move problems is the time (in milliseconds)taken to plan a problem solution for trials requiring 3 moves. Higher numbers indicate poorer performance. Time reported is the difference between baseline and 6 weeks post-treatment.
Outcome measures
| Measure |
Open Label Aripiprazole Augmentation
n=13 Participants
This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
|
|---|---|
|
Stockings of Cambridge (SOC) Mean Initial Thinking Time for 3-move Problems
|
-4485.50 milliseconds
Standard Deviation 6279.40
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PRIMARY outcome
Timeframe: baseline and 6 weeksPopulation: Completers; due to fact that testing occurred at pre- and post-intervention; mean represents difference between pre- and post-intervention
The SOC is part of the CAmbridge Neuropsychological Test Automated Battery (CANTAB) and is an executive function task based on the Tower of London test that assesses spatial planning for problems with 2, 3, 4, or 5 moves. The Mean Initial Thinking Time for 5-move problems is the time (in milliseconds) taken to plan a problem solution for trials requiring 5 moves. Higher numbers indicate poorer performance. Time reported is the difference between baseline and 6 weeks post-treatment.
Outcome measures
| Measure |
Open Label Aripiprazole Augmentation
n=13 Participants
This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
|
|---|---|
|
Stockings of Cambridge (SOC) Mean Initial Thinking Time for 5-move Problems
|
-4676.10 milliseconds
Standard Deviation 8604.16
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PRIMARY outcome
Timeframe: baseline and 6 weeksPopulation: Completers because data were collected pre- and post-treatment
The SWM task is part of the CANTAB neruopsychological test battery and is an executive function task assessing retention and manipulation of items in working memory, with the ability for assessment of perseverative (redundant) errors. Between errors are times the subject revisits a box in which a token was previously found; errors are calculated for 4-, 6-, and 8-box trials. Higher numbers indicate poorer performance. Errors reported are the difference between baseline and 6 weeks post-treatment.
Outcome measures
| Measure |
Open Label Aripiprazole Augmentation
n=13 Participants
This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
|
|---|---|
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Spatial Working Memory (SWM) Between Errors for 6-move Problems
|
-4.00 number of errors
Standard Deviation 4.67
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PRIMARY outcome
Timeframe: baseline and 6 weeksPopulation: Completers; due to fact that testing occurred at pre- and post-intervention; mean represents difference between pre- and post-intervention
The SWM task is part of the CANTAB neruopsychological test battery and is an executive function task assessing retention and manipulation of items in working memory, with the ability for assessment of perseverative (redundant) errors. The Strategy score represents the number of times a participant begins a search with the same box for 6- and 8-box problems. Minimum score is 8 and maximum score is 56. Higher numbers indicate poorer performance. Score reported is the difference between baseline and 6 weeks post-treatment.
Outcome measures
| Measure |
Open Label Aripiprazole Augmentation
n=13 Participants
This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
|
|---|---|
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Spatial Working Memory (SWM) Strategy Score
|
-3.15 units on a scale
Standard Deviation 4.52
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SECONDARY outcome
Timeframe: 6 weeksPopulation: Study completers who completed the Q-LES-Q pre- and post-intervention; mean represents mean difference from pre- to post-intervention
The Q-LES-Q general activities is designed to measure subjective satisfaction and enjoyment, as opposed to function, in various domains including physical health, feelings, work, household duties, school/course work, leisure time activities, social relations, and general activities. The raw score is converted into a percent of the maximum possible score and range from 0 to 100. Higher scores indicate greater enjoyment and satisfaction.
Outcome measures
| Measure |
Open Label Aripiprazole Augmentation
n=12 Participants
This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
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|---|---|
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Quality of Life Enjoyment and Satisfaction Questionnaire
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0.81 units on a scale
Standard Deviation 0.48
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SECONDARY outcome
Timeframe: 6 weeksPopulation: Study completers who completed the HRSD pre- and post-intervention; mean represents mean difference from pre- to post-intervention
The HRSD 17-item scale is a clinician-administered rating scale designed to assess the severity of symptoms in patients diagnosed with depression. Scores range from 0 to 52, with higher scores indicating higher levels of depression severity.
Outcome measures
| Measure |
Open Label Aripiprazole Augmentation
n=12 Participants
This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
|
|---|---|
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Change in Hamilton Rating Scale for Depression (HRSD - 17-item)
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-11.42 units on a scale
Standard Deviation 4.50
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Adverse Events
Open-label Aripiprazole Augmentation
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Open-label Aripiprazole Augmentation
n=17 participants at risk
Aripiprazole augmentation of existing escitalopram, citalopram, or sertraline treatment was provided to study participants at a flexible dose between 5-15 mg (based on clinical symptoms and side effects) for 6 weeks
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|---|---|
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Gastrointestinal disorders
diarrhea
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47.1%
8/17
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Gastrointestinal disorders
constipation
|
47.1%
8/17
|
|
Gastrointestinal disorders
dry mouth
|
35.3%
6/17
|
|
Gastrointestinal disorders
nausea/vomiting
|
17.6%
3/17
|
|
Cardiac disorders
palpitations
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11.8%
2/17
|
|
Cardiac disorders
dizziness on standing
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17.6%
3/17
|
|
Cardiac disorders
chest pain
|
11.8%
2/17
|
|
Skin and subcutaneous tissue disorders
rash
|
11.8%
2/17
|
|
Skin and subcutaneous tissue disorders
increased perspiration
|
35.3%
6/17
|
|
Skin and subcutaneous tissue disorders
itching
|
5.9%
1/17
|
|
Skin and subcutaneous tissue disorders
dry skin
|
5.9%
1/17
|
|
Nervous system disorders
headache
|
82.4%
14/17
|
|
Nervous system disorders
tremors
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23.5%
4/17
|
|
Nervous system disorders
poor coordination
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35.3%
6/17
|
|
Nervous system disorders
dizziness
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29.4%
5/17
|
|
Eye disorders
blurred vision
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29.4%
5/17
|
|
Ear and labyrinth disorders
ringing in the ears
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35.3%
6/17
|
|
Renal and urinary disorders
difficulty urinating
|
5.9%
1/17
|
|
General disorders
general malaise
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47.1%
8/17
|
|
Nervous system disorders
restlessness
|
70.6%
12/17
|
|
General disorders
fatigue
|
76.5%
13/17
|
|
General disorders
decreased energy
|
58.8%
10/17
|
|
Renal and urinary disorders
painful urination
|
5.9%
1/17
|
|
Renal and urinary disorders
frequent urination
|
35.3%
6/17
|
|
Reproductive system and breast disorders
menstrual irregularity
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11.8%
2/17
|
|
Nervous system disorders
difficulty sleeping
|
76.5%
13/17
|
|
Nervous system disorders
sleeping too much
|
52.9%
9/17
|
|
Reproductive system and breast disorders
loss of sexual desire
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64.7%
11/17
|
|
Reproductive system and breast disorders
trouble achieving orgasm
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23.5%
4/17
|
|
Reproductive system and breast disorders
trouble with erections
|
5.9%
1/17
|
|
Nervous system disorders
anxiety
|
58.8%
10/17
|
|
Nervous system disorders
poor concentration
|
17.6%
3/17
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place